AccessGUDID - DEVICE: ORTHO Daily QC Simulated Whole Blood Quality Control Kit (04065266566086)

GUDID

Device Identifier (DI) Information

Brand Name: ORTHO Daily QC Simulated Whole Blood Quality Control Kit
Version or Model: 6708858
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6708858
Company Name: MILLIPORE (U.K.) LIMITED

Primary DI Number: 04065266566086
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 221110203 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
55864	Non-blood cell primer/calibrator/control material IVD, reagent	A substance or reactant intended to be used as a non-blood cell primer, calibrator and/or control to prepare or establish the operational performance of an instrument prior to its use in routine haematological analysis of a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSF	Kit, Quality Control For Blood Banking Reagents

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK210653	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: 2-8oC

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: df6c6067-3ad7-408c-acb2-9f30a7398793
Public Version Date: April 18, 2024
Public Version Number: 1
DI Record Publish Date: April 10, 2024